U.S. patent application number 12/512542 was filed with the patent office on 2011-02-03 for methods and devices for providing access into a body cavity.
This patent application is currently assigned to ETHICON ENDO-SURGERY, INC.. Invention is credited to David T. Martin, Michael V. Scherrill, Catherine A. Teuschler.
Application Number | 20110028793 12/512542 |
Document ID | / |
Family ID | 43527644 |
Filed Date | 2011-02-03 |
United States Patent
Application |
20110028793 |
Kind Code |
A1 |
Martin; David T. ; et
al. |
February 3, 2011 |
METHODS AND DEVICES FOR PROVIDING ACCESS INTO A BODY CAVITY
Abstract
Methods and devices are provided for providing surgical access
into a body cavity. In one embodiment, a surgical access device is
provided that includes a housing having multiple access ports for
receiving surgical instruments, and a retractor removably coupled
to the housing and having a working channel configured to extend
into a body cavity. With the housing and retractor mated together,
a portion of the housing through which instruments can be inserted
can rotate relative to the retractor. The retractor can be
positioned in tissue using an inserter tool configured to seat the
retractor and to automatically release the retractor into position
within the tissue. The retractor can be removed from the tissue
using a cord coupled to the retractor.
Inventors: |
Martin; David T.; (Milford,
OH) ; Teuschler; Catherine A.; (Cincinnati, OH)
; Scherrill; Michael V.; (Batavia, OH) |
Correspondence
Address: |
Ethicon Endo-Surgery/Nutter, McClennen & Fish LLP
Seaport West, 155 Seaport Blvd.
Boston
MA
02210-2604
US
|
Assignee: |
ETHICON ENDO-SURGERY, INC.
Cincinnati
OH
|
Family ID: |
43527644 |
Appl. No.: |
12/512542 |
Filed: |
July 30, 2009 |
Current U.S.
Class: |
600/208 |
Current CPC
Class: |
A61B 17/3474 20130101;
A61B 17/3423 20130101; A61B 17/0293 20130101; A61B 2017/3466
20130101; A61B 2017/3464 20130101 |
Class at
Publication: |
600/208 |
International
Class: |
A61B 1/32 20060101
A61B001/32 |
Claims
1. A surgical access device, comprising: an outer housing defining
a working channel; an inner housing rotatably mated to the outer
housing, the inner housing having a plurality of sealing ports each
configured to receive an instrument inserted therethrough and into
the working channel; and a retractor protector mated to the inner
housing and rotatable with the inner housing relative to the outer
housing.
2. The device of claim 1, wherein the retractor protector comprises
an outer layer and an inner layer disposed within the outer
layer.
3. The device of claim 2, wherein the outer and inner layers each
include a plurality of distally extending fingers, the fingers at
least partially overlapping and engaging one another.
4. The device of claim 1, wherein the outer housing has an
insufflation port extending from a wall thereof, the inner housing
being rotatable relative to the insufflation port.
5. The device of claim 1, further comprising a locking ring
removably mated to the outer housing in one of a plurality of
predetermined positions.
6. The device of claim 5, further comprising a flexible elongate
cannula removably mated to the locking ring.
7. The device of claim 1, further comprising a cap releasably mated
to one of the sealing ports to reduce a diameter of the one of the
sealing ports.
8. The device of claim 1, further comprising a flexible retractor
extending distally from the outer housing, the flexible retractor
having an opening extending therethrough for forming a pathway
through tissue into a body cavity.
9. The device of claim 8, wherein the retractor protector extends
into the opening of the flexible retractor.
10. A surgical access device, comprising: a flexible retractor
configured to be positioned in an opening in tissue; a retractor
ring releasably mated to the flexible retractor; a locking ring
releasably mated to the retractor ring in a fixed position; and an
outer housing releasably mated to the locking ring in a fixed
position, the outer housing having an inner housing rotatably
disposed therein, the inner housing having a plurality of sealing
ports extending therethrough.
11. The device of claim 10, wherein the flexible retractor
comprises a flexible elongate cannula with a flexible proximal ring
member and a flexible distal ring member.
12. The device of claim 11, wherein the retractor ring receives the
flexible proximal ring member therein to releasably mate the
retractor ring to the flexible retractor.
13. The device of claim 10, wherein the outer housing and the
retractor ring each include a beveled surface configured to engage
a proximal portion of the flexible retractor therebetween.
14. The device of claim 10, wherein the locking ring defines a
plurality of predetermined rotational orientations for releasably
mating to the outer housing.
15. The device of claim 10, wherein the outer housing releasably
mates to the locking ring in a plurality of predetermined fixed
positions.
16. The device of claim 10, further comprising a depressible tab on
the outer housing having an engaged position for mating the outer
housing to the locking ring in a fixed position, and having a
released position for allowing release of the outer housing from
the locking ring.
17. The device of claim 10, wherein the outer housing rotates
relative to the locking ring to lock thereto and unlock
therefrom.
18. A surgical method, comprising: positioning a flexible retractor
in an opening in tissue of a patient such that a proximal portion
of the retractor is located outside the patient and a distal
portion of the retractor is disposed in a body cavity underlying
the tissue; mating a retractor ring to the proximal portion of the
flexible retractor located outside the patient; mating a locking
ring to the retractor ring; mating an outer housing to the locking
ring; and inserting an instrument through one of a plurality of
sealing ports in an inner housing rotatably disposed within the
outer housing.
19. The method of claim 18, further comprising manipulating the
instrument to rotate the inner housing relative to the outer
housing.
20. The method of claim 18, wherein inserting the instrument
through one of the plurality of sealing ports in the inner housing
comprises inserting the instrument through a retractor protector
mated to the inner housing and rotatable therewith.
21. The method of claim 18, wherein mating the outer housing to the
locking ring comprises positioning an insufflation port on the
outer housing in a desired rotational position.
22. The method of claim 18, wherein mating the outer housing to the
locking ring comprises locking the outer housing to the locking
ring in one of a plurality of predetermined fixed positions.
23. The method of claim 18, wherein mating the retractor ring to
the proximal portion of the flexible retractor comprises
positioning a flexible proximal ring of the flexible retractor
within the retractor ring.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to methods and devices for
providing surgical access into a body cavity.
BACKGROUND OF THE INVENTION
[0002] Abdominal laparoscopic surgery gained popularity in the late
1980s, when benefits of laparoscopic removal of the gallbladder
over traditional (open) operation became evident. Reduced
postoperative recovery time, markedly decreased post-operative pain
and wound infection, and improved cosmetic outcome are well
established benefits of laparoscopic surgery, derived mainly from
the ability of laparoscopic surgeons to perform an operation
utilizing smaller incisions of the body cavity wall.
[0003] Laparoscopic procedures generally involve insufflation of
the abdominal cavity with CO.sub.2 gas to a pressure of around 15
mm Hg. The abdominal wall is pierced and a 5-10 mm in diameter
straight tubular cannula or trocar sleeve is then inserted into the
abdominal cavity. A laparoscopic telescope connected to an
operating room monitor is used to visualize the operative field,
and is placed through a the trocar sleeve. Laparoscopic instruments
(graspers, dissectors, scissors, retractors, etc.) are placed
through two or more additional trocar sleeves for the manipulations
by the surgeon and surgical assistant(s).
[0004] Recently, so-called "mini-laparoscopy" has been introduced
utilizing 2-3 mm diameter straight trocar sleeves and laparoscopic
instruments. When successful, mini-laparoscopy allows further
reduction of abdominal wall trauma and improved cosmesis.
Instruments used for mini-laparoscopic procedures are, however,
generally more expensive and fragile. Because of their performance
limitations, due to their smaller diameter (weak suction-irrigation
system, poor durability, decreased video quality),
mini-laparoscopic instruments can generally be used only on
selected patients with favorable anatomy (thin cavity wall, few
adhesions, minimal inflammation, etc.). These patients represent a
small percentage of patients requiring laparoscopic procedures. In
addition, smaller 2-3 mm incisions may still cause undesirable
cosmetic outcomes and wound complications (bleeding, infection,
pain, keloid formation, etc.).
[0005] Since the benefits of smaller and fewer body cavity
incisions are proven, it would be desirable to perform an operation
utilizing only a single incision. An umbilicus is well-hidden and
the thinnest and least vascularized area of the abdominal wall. The
umbilicus is generally a preferred choice of abdominal cavity entry
in laparoscopic procedures. An umbilical incision can be easily
enlarged (in order to eviscerate a larger specimen) without
significantly compromising cosmesis and without increasing the
chances of wound complications.
[0006] Thus, there is a need for instruments and trocar systems
which allow laparoscopic procedures to be performed entirely
through the umbilicus or a surgical port located elsewhere while at
the same time allowing adjustment of instrument position during the
surgical procedure.
SUMMARY OF THE INVENTION
[0007] The present invention generally provides methods and devices
for providing surgical access into a body cavity. In one
embodiment, a surgical access device is provided that includes an
outer housing defining a working channel, an inner housing
rotatably mated to the outer housing, and a retractor protector
mated to the inner housing and rotatable with the inner housing
relative to the outer housing. The inner housing has a plurality of
sealing ports each configured to receive an instrument inserted
therethrough and into the working channel.
[0008] The surgical access device can vary in any number of ways.
The outer housing can have an insufflation port extending from a
wall thereof, and the inner housing can be rotatable relative to
the insufflation port. A locking ring can be removably mated to the
outer housing in one of a plurality of predetermined positions, and
a flexible elongate cannula can be removably mated to the locking
ring. A cap can be releasably mated to one of the sealing ports to
reduce a diameter of the one of the sealing ports. A flexible
retractor can extend distally from the outer housing and have an
opening extending therethrough for forming a pathway through tissue
into a body cavity. The retractor protector can extend into the
opening of the flexible retractor.
[0009] The retractor protector can have a variety of
configurations. In one embodiment, the retractor protector can
include an outer layer and an inner layer disposed within the outer
layer. The outer and inner layers can each include a plurality of
distally extending fingers that at least partially overlap and
engage one another.
[0010] In another embodiment, a surgical access device is provided
that includes a flexible retractor configured to be positioned in
an opening in tissue, a retractor ring releasably mated to the
flexible retractor, a locking ring releasably mated to the
retractor ring in a fixed position, and an outer housing releasably
mated to the locking ring in a fixed position. The outer housing
has an inner housing rotatably disposed therein, and the inner
housing has a plurality of sealing ports extending
therethrough.
[0011] The surgical access device can have any number of
variations. The flexible retractor can include a flexible elongate
cannula with a flexible proximal ring member and a flexible distal
ring member. The retractor ring can receive the flexible proximal
ring member therein to releasably mate the retractor ring to the
flexible retractor. The outer housing and the retractor ring can
each include a beveled surface configured to engage a proximal
portion of the flexible retractor therebetween. The locking ring
can define a plurality of predetermined rotational orientations for
releasably mating to the outer housing. The outer housing can
releasably mate to the locking ring in a plurality of predetermined
fixed positions. A depressible tab on the outer housing can have an
engaged position for mating the outer housing to the locking ring
in a fixed position, and can have a released position for allowing
release of the outer housing from the locking ring. The outer
housing can rotate relative to the locking ring to lock thereto and
unlock therefrom.
[0012] In another aspect, a surgical method is provided that
includes positioning a flexible retractor in an opening in tissue
of a patient such that a proximal portion of the retractor is
located outside the patient and a distal portion of the retractor
is disposed in a body cavity underlying the tissue, mating a
retractor ring to the proximal portion of the flexible retractor
located outside the patient, mating a locking ring to the retractor
ring, mating an outer housing to the locking ring, and inserting an
instrument through one of a plurality of sealing ports in an inner
housing rotatably disposed within the outer housing.
[0013] In some embodiments, mating the outer housing to the locking
ring can include positioning an insufflation port on the outer
housing in a desired rotational position. Alternatively or
additionally, mating the outer housing to the locking ring can
include locking the outer housing to the locking ring in one of a
plurality of predetermined fixed positions.
[0014] The method can have any number of other variations. For
example, the method can include manipulating the instrument to
rotate the inner housing relative to the outer housing. For another
example, inserting the instrument through one of the plurality of
sealing ports in the inner housing can include inserting the
instrument through a retractor protector mated to the inner housing
and rotatable therewith. For yet another example, mating the
retractor ring to the proximal portion of the flexible retractor
can include positioning a flexible proximal ring of the flexible
retractor within the retractor ring.
[0015] In yet another aspect, an inserter tool is provided that
includes an elongate shaft having a proximal handle portion and a
flexible distal portion. The flexible distal portion has opposed
side rails that define a channel extending longitudinally through
at least a portion of the flexible distal portion. The channel
includes first and second longitudinally extending recesses
configured to seat opposed portions of a flexible ring. The
flexible distal portion includes first and second retention members
extending from the opposed side rails and toward the channel such
that the retention members are configured to prevent the flexible
ring from being pulled laterally out of the channel.
[0016] The inserter tool can vary in any number of ways. The
flexible distal portion can have a thickness that is less than a
thickness of the proximal handle portion. In some embodiments, the
elongate shaft can have indicia thereon configured to indicate an
insertion depth of the elongate shaft through an opening in tissue
and into a body cavity.
[0017] In still another aspect, a surgical kit is provided that
includes a cannula having proximal and distal flexible annular
rings, and a flexible sidewall extending between the proximal and
distal flexible annular rings and defining an inner lumen extending
through the cannula. The kit also include an inserter tool having a
handle and a flexible elongate shaft extending from the handle. The
flexible elongate shaft includes a channel extending longitudinally
therethrough and configured to seat one of the proximal and distal
flexible annular rings to retain the seated annular ring in a
collapsed configuration. The kit can optionally include a proximal
assembly configured to mate to the proximal flexible annular ring
and including a plurality of sealing ports each configured to
receive an instrument inserted therethrough and into the inner
lumen extending through the cannula. The proximal assembly can have
a variety of configurations. In some embodiments the proximal
assembly can include a retractor ring releasably matable to the
proximal flexible annular ring, a locking ring releasably matable
to the retractor ring in a fixed position, and a housing releasably
matable to the locking ring in a fixed position. The housing can
also have a variety of configurations, such as including an outer
housing releasably matable to the locking ring in a fixed position.
The outer housing can have an inner housing rotatably disposed
therein and having the plurality of sealing ports.
[0018] In another aspect, a surgical method is provided that
includes positioning a distal annular ring on a cannula within a
channel extending longitudinally through a flexible distal portion
of an insertion tool such that the channel retains the distal
annular ring in a collapsed configuration. The distal annular ring
is coupled to a proximal annular ring by a flexible sidewall
defining an inner lumen extending between the proximal and distal
annular rings. The method also includes advancing the flexible
distal portion of the insertion tool through tissue such that the
proximal annular ring on the cannula abuts an outer surface of the
tissue and causes the flexible distal portion to flex. The channel
releases the distal annular ring when a predetermined force is
applied to the channel. In some embodiments, at least one retention
member on the flexible distal portion extending toward the channel
can move away from the channel when the predetermined force is
applied to the channel to release the distal annular ring from the
channel.
[0019] The method can vary in any other number of ways. For
example, the method can include attaching a proximal assembly to
the proximal annular ring when the proximal annular ring on the
cannula abuts the outer surface of the tissue. An instrument can be
inserted through one of a plurality of sealing ports in the
proximal assembly and through the inner lumen of the cannula to
position a distal portion of the instrument in a body cavity
underlying the tissue. For another example, the method can include
pulling a cord extending through the inner lumen, around the distal
annular ring, and between the flexible sidewall and the tissue to
pull the distal annular ring through the tissue to remove the
cannula from the tissue.
[0020] In another aspect, a surgical method is provided that
includes implanting a cannula through an incision in tissue to
position a proximal annular ring adjacent to an outer surface of
the tissue and to position a distal annular ring adjacent to an
inner surface of the tissue such that a flexible sidewall extending
between the proximal and distal annular rings forms an opening
through the tissue. The cannula has a cord extending through the
opening, around the distal annular ring, and between the flexible
sidewall and the tissue. The cord is pulled to pull the distal
annular ring through the tissue to remove the cannula from the
tissue. The method can have any number of variations.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The invention will be more fully understood from the
following detailed description taken in conjunction with the
accompanying drawings, in which:
[0022] FIG. 1 is a perspective view of one embodiment of a surgical
access device;
[0023] FIG. 2 is an exploded view of the device of FIG. 1;
[0024] FIG. 3 is a side, cross-sectional view of the device of FIG.
1;
[0025] FIG. 4 is a top view of a housing of the device of FIG.
1;
[0026] FIG. 5 is a side, cross-sectional view of the housing of
FIG. 4;
[0027] FIG. 6 is another side, cross-sectional view of the housing
of FIG. 4;
[0028] FIG. 7 is an exploded view of the housing of FIG. 4;
[0029] FIG. 8 is a perspective view of a ring assembly and a
retractor of the device of FIG. 1;
[0030] FIG. 9 is an exploded view of the ring assembly and the
retractor of FIG. 8;
[0031] FIG. 10 is an exploded view of a lower portion of the
housing of FIG. 4 and a locking ring of the ring assembly of FIG.
8;
[0032] FIG. 11 is a side view of the retractor of FIG. 8 with its
distal flange being flexed;
[0033] FIG. 12 is a side view of the retractor of FIG. 11 with the
distal flange being pushed proximally through an inner lumen of the
retractor;
[0034] FIG. 13 is a side, partially cross-sectional view of the
retractor of FIG. 12 being positioned by hand in an opening formed
in tissue;
[0035] FIG. 14 is a side, partially cross-sectional view of the
retractor of FIG. 8 positioned in an opening formed in the tissue
and having its position therein being tactilely verified;
[0036] FIG. 15 is a perspective view of one embodiment of an
inserter tool;
[0037] FIG. 16 is a top view of the inserter tool of FIG. 15;
[0038] FIG. 17 is a side, cross-sectional view of the inserter tool
of FIG. 15;
[0039] FIG. 18 is a side view of the inserter tool of FIG. 15;
[0040] FIG. 19 is a cross-sectional view of a distal portion of the
inserter tool of FIG. 15;
[0041] FIG. 20 is another cross-sectional view of a distal portion
of the inserter tool of FIG. 15;
[0042] FIG. 21 is a perspective view of the retractor of FIG. 8
being attached to the inserter tool of FIG. 15;
[0043] FIG. 22 is a top, partial view of the retractor of FIG. 21
disposed in a channel of the inserter tool;
[0044] FIG. 23 is a side, partially cross-sectional view of the
retractor of FIG. 22 mated to the inserter tool and being inserted
in an opening formed in tissue;
[0045] FIG. 24 is a side, partially cross-sectional view of the
retractor of FIG. 23 mated to the inserter tool and partially
inserted in the opening formed in tissue;
[0046] FIG. 25 is a side, partially cross-sectional view of the
retractor of FIG. 24 released from the inserter tool and positioned
in the opening formed in tissue;
[0047] FIG. 26 is a perspective view of the ring assembly of FIG. 8
being attached to the retractor of FIG. 25 positioned in the
opening formed in tissue;
[0048] FIG. 27 is a perspective view of the housing of FIG. 4 being
attached to the ring assembly and the retractor of FIG. 26;
[0049] FIG. 28 is a side, partially cross-sectional view of the
assembled housing, ring assembly, and retractor of FIG. 27
positioned in the opening formed in tissue and having a surgical
instrument inserted therethrough;
[0050] FIG. 29 is a side, partially cross-sectional view of one
embodiment of a cord being inserted through an opening formed in
tissue;
[0051] FIG. 30 is a side view of the retractor of FIG. 8 attached
to the inserter tool of FIG. 15 and being inserted into the tissue
opening of FIG. 29 with the cord inserted therethrough;
[0052] FIG. 31 is a side view of the retractor and the inserter
tool of FIG. 30 more deeply inserted into the tissue opening;
[0053] FIG. 32 is a side, partially-cross sectional view of the
retractor of FIG. 31 positioned in the opening formed in tissue
with the cord being positioned between the tissue and the
retractor, around a distal end of the retractor, and through an
inner lumen of the retractor;
[0054] FIG. 33 is a perspective view of the retractor of FIG. 8
mated to the inserter tool of FIG. 15 with one embodiment of a cord
threaded through an inner lumen of the retractor;
[0055] FIG. 34 is a top view of the retractor of FIG. 32 with the
ring assembly of FIG. 4 attached thereto and with the cord being
manipulated to remove the retractor from the opening formed in
tissue; and
[0056] FIG. 35 is a perspective view of the retractor and ring
assembly of FIG. 33 with the cord being used to pull a distal end
of the retractor through the retractor's inner lumen to remove the
retractor from the opening formed in tissue.
DETAILED DESCRIPTION OF THE INVENTION
[0057] Certain exemplary embodiments will now be described to
provide an overall understanding of the principles of the
structure, function, manufacture, and use of the devices and
methods disclosed herein. One or more examples of these embodiments
are illustrated in the accompanying drawings. Those skilled in the
art will understand that the devices and methods specifically
described herein and illustrated in the accompanying drawings are
non-limiting exemplary embodiments and that the scope of the
present invention is defined solely by the claims. The features
illustrated or described in connection with one exemplary
embodiment may be combined with the features of other embodiments.
Such modifications and variations are intended to be included
within the scope of the present invention.
[0058] Various exemplary methods and devices are provided for
providing surgical access into a body cavity. In general, the
methods and devices allow multiple surgical instruments to be
inserted through independent access ports in a single surgical
access device and into a body cavity. The instruments can be
collectively rotatable about a central axis of the device, thus
allowing for ease of manipulation within a patient's body. In one
embodiment, a surgical access device includes a housing having
multiple access ports or sealing ports for receiving surgical
instruments, and a retractor removably coupled to the housing and
having a working channel configured to extend into a body cavity.
Each sealing port can include one or more sealing elements therein
for sealing the port and/or forming a seal around a surgical
instrument disposed therethrough. Mating features can be configured
to align the housing and the retractor in a predetermined position
relative to one another to allow for easy attachment and removal of
the housing to and from the retractor. Once mated, a portion of the
housing through which instruments can be inserted can rotate
relative to the retractor, thereby helping to optimally position
instruments inserted therethrough and into the body cavity in which
the retractor extends. The device can also include at least one
safety shield extending from the housing into the retractor to help
protect the retractor from being damaged by instruments passed
through the retractor's working channel.
[0059] The surgical access device can be positioned in an opening
in tissue in any way to provide a working channel through the
tissue to provide access to a body cavity underlying the tissue. In
another general aspect, the methods and devices allow a surgical
access device to be positioned in an opening in tissue with an
inserter tool. The inserter tool can include an elongate shaft
having a flexible distal end configured to releasably mate to at
least a portion of the surgical access device. In one embodiment,
the retractor of the surgical access device can be releasably
coupled to the flexible distal end of the inserter tool. The
inserter tool's distal end with the retractor attached thereto can
be inserted through a tissue opening, with the inserter tool being
configured to automatically release the retractor therefrom when
the retractor extends through the tissue opening with opposed
terminal ends of the retractor positioned on opposite sides of the
tissue. The retractor can thereby be positioned easily, accurately,
and hands-free in any sized tissue opening using a single, reusable
surgical tool. The housing of the surgical access device can be
mated to the retractor, either before, or in an exemplary
embodiment, after the retractor is positioned in tissue. In some
embodiments, the retractor can be removed from the tissue using a
cord coupled to the retractor.
[0060] As indicated above, the various surgical access devices can
include a wound protector, cannula, or other member for forming a
pathway through tissue (hereinafter generally referred to as a
retractor). The retractor can extend from the housing and it can be
configured to be positioned within an opening in a patient's body,
such as the umbilicus. The sealing ports can each define working
channels extending through the housing and aligned with the
retractor. Any and all of the surgical access devices described
herein can also include various other features, such as one or more
ventilation ports to allow evacuation of smoke during procedures
that utilize cautery, and/or one or more insufflation ports through
which the surgeon can insufflate the abdomen to cause
pneumoperitenium, as described by way of non-limiting example in
U.S. Patent Application No. 2006/0247673 entitled "Multi-port
Laparoscopic Access Device" filed Nov. 2, 2006, which is hereby
incorporated by reference in its entirety. The insufflation port
can be located anywhere on the device, can have any size, and can
accept a leur lock or a needle, as will be appreciated by those
skilled in the art.
[0061] As discussed further below, any and all embodiments of a
surgical access device can also include one or more retractor
protectors or safety shields positioned through, in, and around any
of the components and/or tissue to protect the components against
puncture or tear by surgical instruments being inserted through the
device. In addition, any and all embodiments of a surgical access
device can include engagement and release mechanisms that allow
certain components of the surgical access device to be removable as
needed.
[0062] In use, and as also further discussed below, the surgical
access devices disclosed herein can provide access to a patient's
body cavity. The retractor can be positionable within an opening in
a patient's body such that a distal portion of the retractor
extends into a patient's body cavity and a proximal portion
configured to couple to the housing is positioned adjacent to the
patient's skin on an exterior of the patient's body. A lumen in the
retractor can form a pathway through the opening in a patient's
body so that surgical instruments can be inserted from outside the
body to an interior body cavity. The elasticity of the skin of the
patient can assist in the retention of the retractor in the body
opening or incision made in the body. The retractor can be placed
in any opening within a patient's body, whether a natural orifice
or an opening made by an incision. In one embodiment, the retractor
can be substantially flexible so that it can easily be maneuvered
into and within tissue as needed. In other embodiments, the
retractor can be substantially rigid or substantially semi-rigid.
The retractor can be formed of any suitable material known in the
art, e.g., silicone, urethane, thermoplastic elastomer, and rubber.
Non-limiting examples of retractors include a Hakko.RTM. Wound
Protector available from Hakko Medical Co. of Tokyo, Japan, an
Alexis.RTM. Wound Protector available from Applied Medical
Resources Corp. of Rancho Santa Margarita, Calif., and a
Mobius.RTM. Retractor available from Apple Medical Corp. of
Marlborough, Mass.
[0063] Typically, during surgical procedures in a body cavity, such
as the abdomen, insufflation is provided through the surgical
access device to expand the body cavity to facilitate the surgical
procedure. Thus, in order to maintain insufflation within the body
cavity, most surgical access devices include at least one seal
disposed therein to prevent air and/or gas from escaping when
surgical instruments are inserted therethrough. Various sealing
elements are known in the art, but typically the surgical access
device can include at least one instrument seal that forms a seal
around an instrument disposed therethrough, but otherwise does not
form a seal when no instrument is disposed therethrough, at least
one channel seal or zero-closure seal that seals the working
channel created by the sealing port when no instrument is disposed
therethrough, or a combination instrument seal and channel seal
that is effective to both form a seal around an instrument disposed
therethrough and to form a seal in the working channel when no
instrument is disposed therethrough. A person skilled in the art
will appreciate that various seals known in the art can be used
including, e.g., duckbill seals, cone seals, flapper valves, gel
seals, diaphragm seals, lip seals, iris seals, etc. A person
skilled in the art will also appreciate that any combination of
seals can be included in any of the embodiments described herein,
whether or not the seal combinations are specifically discussed in
the corresponding description of a particular embodiment.
[0064] In an exemplary embodiment, shown in FIGS. 1-3, a surgical
access device 10 is provided having a proximal portion 24 including
a housing 12 and a ring assembly 26, and a distal portion 20
including a retractor 18 having an inner pathway, inner lumen, or
working channel 18a extending therethrough. As shown in the
illustrated embodiment, the housing 12 can be configured to have
one or more surgical instruments inserted therethrough and can
include an outer housing 14 and an inner housing 16 that defines at
least one sealing or access port. While the inner housing 16 can
define any number of sealing ports, in the illustrated embodiment,
the inner housing 16 defines first, second, and third sealing ports
22a, 22b, 22c that extend through the inner housing 16 and that
respectively seat first, second, and third sealing elements, as
discussed further below. The housing 12 can be removably coupled to
the ring assembly 26, which in the illustrated embodiment includes
a locking ring 28 and a retractor ring 30 configured to releasably
or fixedly mate to each other. The housing 12 can be configured to
releasably mate to the locking ring 28, and the retractor ring 30
can be configured to releasably mate to the retractor 18. The
retractor 18 can thus be configured to distally extend from the
housing 12 and to provide a pathway through tissue into a body
cavity. In the embodiment shown, the retractor 18 is flexible and
has a proximal flange 29 and a distal flange 31 with an inner
elongate portion 32 extending therebetween. The inner housing 16
can be movable with respect to the outer housing 14 and the
retractor 18, as will be discussed in more detail below. Such a
configuration can help facilitate instrument positioning in a body
cavity to which the device 10 provides access.
[0065] The device 10 can also include an insufflation port 34 in
the outer housing 14, although a person skilled in the art will
appreciate that the insufflation port 34 can be located elsewhere
in the housing 12 or in other locations. A person skilled in the
art will also appreciate that the insufflation port 34 can have a
variety of configurations. Generally, the insufflation port 34 can
be configured to pass an insufflation fluid through a flexible
insufflation tube 36 and into an insufflation orifice of the
insufflation port 34 where the fluid can flow between the outer
housing 14 and the inner housing 16, into the retractor's pathway
18a, and into a body cavity. A stopcock 38 can control fluid flow
through the insufflation tube 36. As discussed further below, by
having the insufflation port 34 extend from the outer housing 14,
the insufflation port 34 can be configured to have a fixed
rotational orientation relative to the retractor 18 regardless of
the rotational orientation of the inner housing 16 relative to the
outer housing 14, thereby reducing chances of the tube 36 twisting
and/or becoming blocked or severed when the inner housing 16
rotates. In this way, the insufflation port 34 and the tube 36
extending therefrom can be selectively positioned at a location
less likely to cause interference with surgical instruments and/or
surgical staff during a surgical procedure.
[0066] The housing 12 of the surgical access device 10 can have a
variety of configurations. As shown in this embodiment, the outer
housing 14 can be configured to rotatably seat the inner housing
16, and the ring assembly 26 can be in the form of two rings, e.g.,
the locking ring 28 and the retractor ring 30, configured to be
disposed between the housing 12 and the retractor 18 to releasably
mate and form a seat and seal between the housing 12 and a distal
portion of the device 10, e.g., the retractor 18. The retractor 18,
the inner housing 16, the outer housing 14, and the ring assembly
26 can each have various sizes, shapes, and configurations, as
discussed further below.
[0067] As noted above, the retractor 18 can extend distally from
the proximal portion 24 of the device 10, and it can be configured
to be positioned in an opening formed in tissue. The inner elongate
portion 32 of the retractor 18 can have a diameter less than a
diameter of the proximal and distal flanges 29, 31, which can have
the same diameter or different diameters from one another. The
proximal flange 29 can be configured to be seated within the
retractor ring 30, as shown in FIGS. 4 and 5, and optionally
attached thereto using an adhesive, sealant, complementary threads,
or any other attachment mechanism, as will be appreciated by a
person skilled in the art. A proximal o-ring 29a can be optionally
positioned within the proximal flange 29 to help provide structural
support to the retractor 18 within the retractor ring 30. A distal
o-ring 31a can optionally be positioned within the distal flange 31
to provide structural support to the retractor 18 within a
patient's body. The proximal and distal o-rings 29a, 31a in this
embodiment are substantially flexible, but one or both can be
substantially flexible or substantially rigid as needed for use in
a particular application. The retractor 18 can be molded as a
cylindrical tube having a substantially constant diameter. The
proximal and distal flanges 29, 31 can be formed by stretching
proximal and distal ends of the cylindrical tube respectively
around the proximal and distal o-rings 29a, 31a to form the
proximal and distal flanges 29, 31 having larger diameters than the
inner elongate portion 32. A person skilled in the art will
appreciate that the o-rings 29a, 31a can be positioned in the
proximal and distal flanges 29, 31 in any way, such as by
stretching and folding ends of the molded retractor around the
o-rings 29a, 31a and bonding the edges around the o-rings 29a,
31a.
[0068] The housing 12 can include, as illustrated in FIGS. 1-7, the
outer housing 14 having upper and lower portions 14a, 14b fixedly
coupled together to define a working channel extending therethrough
and to form a substantially rigid cylindrical or circular member.
The inner housing 16 can also include upper and lower portions 16a,
16b fixedly coupled together to form a substantially rigid
cylindrical or circular member. The inner housing 16 can be movably
seated in the outer housing's working channel, as discussed further
below. One or more seal members can be positioned between the outer
and inner housings 14, 16 to help form a seat and seal
therebetween. In the illustrated embodiment, a proximal o-ring 40
is positioned between the upper portions 14a, 16a of the outer and
inner housings 14, 16. The proximal o-ring 40 can be positioned
proximal to the insufflation port 34 to allow fluid to flow
distally between the outer and inner housings 14, 16 and into the
retractor 18 and a body of a patient. A retractor protector 42 and
a retractor protector retainer 44 in the illustrated embodiment are
positioned between the lower portions 14b, 16b of the outer and
inner housings 14, 16.
[0069] As surgical instruments are inserted through the surgical
access device embodiments described herein, a risk can exist that a
particularly sharp instrument may tear or puncture a portion of the
retractor or nearby tissue. Accordingly, in any and all of the
embodiments described herein, a retractor protector or safety
shield can optionally be included to reduce the risk of tearing or
puncture by a surgical instrument. In general the retractor
protector can be of a material that is relatively smooth and with a
low coefficient of friction to allow ease of passage of
instruments, but resistant to tearing and puncture. For example,
the retractor protector can be formed of silicone, urethane,
thermoplastic elastomer, rubber, polyolefins, polyesters, nylons,
fluoropolymers, and any other suitable materials known in the art.
The retractor protector can generally provide a liner for a
retractor or tissue and can be detachable from a surgical access
device so it can be used as needed in a particular procedure.
[0070] In the illustrated embodiment, the device 10 includes the
retractor protector 42 as part of the proximal portion 24 of the
device 10 that is releasably matable to the device's distal portion
20, although a retractor protector 42 can be part of the proximal
portion 24 or the distal portion 20 of the device 10. The retractor
protector 42 can be configured to extend at least partially into
the inner lumen 18a of the retractor 18 to thereby provide a
protective lining as surgical instruments are inserted through the
device 10. The retractor protector 42 can have a length
corresponding to a length of the retractor 18, but can also have a
length less than (as shown) or considerably longer than the length
of the retractor 18 depending on a specific application. The
retractor protector 42 can be mated to the device's proximal
portion 24, e.g., the housing 12, using any attachment mechanism,
e.g., adhesive, screws, press fit, etc., as will be appreciated by
a person skilled in the art. As illustrated, the retractor
protector 42 can be configured to be held by press fit between a
proximal surface 44a of the retractor protector retainer 44 and a
distal surface of the lower portion 16b of the inner housing 16. A
distal surface 44b of the retractor protector retainer 44 can
slidably engage an inner radially-inward extending circumferential
lip 14c of the outer housing's lower portion 14b. The retractor
protector 42 can thereby move with the inner housing 16 relative to
the outer housing 14 and the retractor 18, as discussed further
below.
[0071] The retractor protector 42 can have any size, shape, and
configuration. In the illustrated embodiment, the retractor
protector 42 includes a circumferentially expandable, cone-shaped
member having an outer layer 42a and an inner layer 42b configured
to be disposed within the outer layer 42a. The outer and inner
layers 42a, 42b can each respectively include a continuous
circumferential proximal rim 46a, 46b extending radially outward as
shown in this embodiment, or one or both can have a plurality of
flanges extending radially outward therefrom. The outer and inner
layers 42a, 42b can include any number of flanges, and the flanges
can be spaced equidistantly or any other distance apart from one
another around their respective proximal rims 46a, 46b. The outer
and inner flanges can each be configured to at least partially
overlap to form a continuous proximal flange of the retractor
protector 42. Alternatively, a portion of the outer and inner
flanges can be configured to engage one another to form a "broken"
proximal flange of the retractor protector 42. In other
embodiments, none of the outer and inner flanges can overlap one
another when the inner layer 42b is disposed in the outer layer
42a.
[0072] The outer and inner layers 42a, 42b of the retractor
protector 42 can also include a plurality of respective distal
elongate fingers 48a, 48b distally extending from the proximal rims
46a, 46b and configured to at least partially overlap and engage
one another when the inner layer 42b is disposed in the outer layer
42a to form a continuous distal surface to help protect an entire
circumference of an inner wall of the inner elongate portion 32 of
the retractor 18. The distal fingers 48a, 48b can thus be
configured to protect the inner elongate portion 32 of the
retractor 18 from damage, but they can be configured to be
selectively movable when in contact with a surgical instrument such
that the surgical instrument can optionally push between the distal
fingers 48a, 48b to help provide the surgical instrument with free
angular range of motion through the device 10. The distal fingers
48a, 48b can also be configured to be selectively movable when the
retractor 18 bends when in position in tissue, if the retractor 18
is flexible. The retractor protector 42 can include any number of
distal fingers 48a, 48b, e.g., six outer and six inner fingers 48a,
48b.
[0073] A retractor protector can include a plurality of layers as
discussed above, or a retractor protector can be a singular member,
which can make the retractor protector easier to dispose in a
retractor. Exemplary singular member retractor protectors are
described in more detail in U.S. patent application Ser. No.
12/399,625 entitled "Methods And Devices For Providing Access Into
A Body Cavity," filed on Mar. 6, 2009, which is hereby incorporated
by reference in its entirety. Exemplary embodiments of various
safety shields are described in more detail in previously mentioned
U.S. Patent Application No. 2006/0247673 entitled "Multi-port
Laparoscopic Access Device" filed Nov. 2, 2006 and in U.S.
application Ser. No. 12/399,482 entitled "Methods and Devices for
Providing Access to a Body Cavity" filed on Mar. 6, 2009 and in
U.S. application Ser. No. 12/242,765 entitled "Surgical Access
Device" filed on Sep. 30, 2008, which are hereby incorporated by
reference in their entireties.
[0074] The inner housing 16 can have a variety of sizes, shapes,
and configurations, as can the sealing ports 22a, 22b, 22c formed
therein. As shown in FIG. 7, the sealing ports 22a, 22b, 22c can be
defined by cut-outs or openings 50a, 50b, 50c in the upper portion
16a of the inner housing 16 and corresponding cut-outs or openings
51a, 51b, 51c in the lower portion 16b of the inner housing 16. The
openings 50a, 50b, 50c can extend through a proximal surface 16p of
the inner housing's upper portion 16a such that they are exposed
within the working channel defined by the outer housing 14, and the
openings 51a, 51b, 51c in the lower portion 16b can be aligned with
the openings 50a, 50b, 50c in the upper portion 16a such that
surgical instruments can be inserted into the openings 50a, 50b,
50c, 51a, 51b, 51c and into the retractor 18. A person skilled in
the art will appreciate that there can be any number of sealing
ports formed in the inner housing 16 that can be arranged in any
way in the inner housing 16. As shown in the illustrated
embodiment, each of the sealing ports 22a, 22b, 22c can share a
central axis that extends substantially perpendicular to a plane of
the proximal surface 16p of the inner housing 16 and that is
substantially parallel to a longitudinal axis of the retractor 18.
The sealing ports 22a, 22b, 22c can each be in a fixed position
relative to the inner housing 16, but any one or more components in
each sealing port can be angled relative to the inner housing 16
and/or rotatable or otherwise movable relative to the inner housing
16 and/or other portion(s) of the housing 12. The sealing ports
22a, 22b, 22c can be radially arranged around a central axis or
center-point of the housing 12, e.g., a central axis or
center-point of the inner housing 16, such that each of the sealing
ports 22a, 22b, 22c can have a central axis that differs from
central axes of the other sealing ports 22a, 22b, 22c. Each of the
sealing ports 22a, 22b, 22c can have central axes located any
distance from the center point of the housing 12. In an exemplary
embodiment, to optimize instrument movement, the central axes can
be located about 1.015 in. (2.58 cm) from the housing's center
point for the larger port 22a and about 0.9 in (2.29 cm) from the
housing's center point for the smaller ports 22b, 22c.
[0075] The upper openings 50a, 50b, 50c and the lower openings 51a,
51b, 51c can also have any combination of sizes and shapes. As
shown, the port openings can each have a shape corresponding to a
shape of the sealing element seated therein, which in the
illustrated embodiment is substantially circular as will be
discussed further below. In an exemplary embodiment, the first port
opening has a first diameter D1 that is larger than a second
diameter D2 of the second and third port openings. For non-limiting
example, the housing 12 can have a diameter of about 75 mm, the
second diameter D2 can be in a range of about 6.0 to 7.5 mm, e.g.,
about 6.2 mm, and the first diameter D1 can be about 15.9 mm, e.g.,
about three times the second diameter D2.
[0076] The device 10 can optionally include at least one reducer
cap selectively and removably matable to any of the sealing ports
22a, 22b, 22c to reduce a diameter thereof to allow a smaller
surgical instrument to be inserted centrally therethrough while
maintaining channel and instrument seals. The reducer cap can be
mated to a sealing port in any way, such as by snap-fit. The
reducer cap 52 can have a variety of shapes, sizes, and
configurations. As shown in this embodiment, a reducer cap 52 can
be pre-attached and removably matable to the larger, first port
opening 22a to reduce the first diameter D1, e.g., from about 15 mm
to about 5 mm. Also as shown in this embodiment, the reducer cap 52
can have a substantially circular proximal portion having a distal
conical portion extending therefrom with an inner lumen extending
through the proximal and distal portions. The reducer cap's inner
lumen can be in communication with a working channel of a sealing
port to which it is mated such that a surgical instrument can be
inserted through the reducer cap 52 and into the sealing element
seated in its associated sealing port. The reducer cap 52 can
include a hand-hold, e.g., a tab 52a extending radially-outward in
the proximal portion of the reducer cap 52, to help ease attachment
and removal of the reducer cap 52 with the inner housing 16. In
some embodiments, the reducer cap 52 can be removably matable to a
sealing element disposed in a sealing port in addition to or
instead of removably mating to the sealing port.
[0077] In some embodiments, the proximal surface 16p of the upper
portion 16a of the inner housing 16 can be substantially flat with
the port openings 50a, 50b, 50c being formed in a same plane with
each other, either co-planar parallel to the proximal surface 16p
or recessed in the inner housing 16. Moreover, as shown in the
embodiment in FIGS. 2 and 7, the proximal surface 16p of the upper
portion 16a of the inner housing 16 can be non-planar with at least
one recessed portion 16r extending in a plane distally displaced
from and substantially parallel to a plane of the proximal surface
16p, and/or at least one raised portion 16s proximally displaced
from and substantially parallel to a plane of the proximal surface
16p. The inner housing's one or more recessed portions and one or
more raised portions can help compensate for sealing elements of
different lengths to help prevent distal seal element openings of
each of the sealing elements from contacting an interior of the
retractor 18, at least when the surgical access device 10 is in a
default position, e.g., as illustrated in FIGS. 1 and 3, and at
least when the device 10 is not positioned in tissue and has no
surgical instruments inserted therethrough.
[0078] In the illustrated embodiment, the lower portion 16b of the
inner housing 16 has raised or proximally extending housings 54a,
54b, 54c that define the first, second, and third openings 51a,
51b, 51c in the inner housing's lower portion 16b. The second and
third raised housings 54b, 54c have a larger height than the first
raised housing 54a, but the raised housings 54a, 54b, 54c can have
any height, same or different from any other raised housings,
configured to help provide clearance room for the sealing elements
seated therein to help prevent the sealing elements from contacting
the retractor 18, as discussed below, at least when the surgical
access device 10 is in the default position.
[0079] The sealing elements disposed in each sealing port 22a, 22b,
22c can be attached or mated to the inner housing 16 using any
attachment or mating mechanism known in the art, but in the
illustrated embodiment the sealing elements are engaged by an
interference fit between the upper and lower portions 16a, 16b of
the inner housing 16. In general, each of the sealing ports 22a,
22b, 22c can include an instrument seal and a channel or
zero-closure seal disposed therein.
[0080] The sealing elements can have a variety of sizes, shapes,
and configurations. As shown in the illustrated embodiment in FIG.
7, the first sealing element includes a fan seal 58, a fan seal
protector 56 positioned concentric with and proximal to the fan
seal 58, and a bottom ring 60 in which the fan seal 58 can be
concentrically seated with the fan seal protector 56 to together
form the instrument seal in the larger sealing port 22a. A distal
duckbill seal 62 can be positioned concentric and distal to the
bottom ring 60, and thus the bottom ring 60 can act as a spacer to
separate the fan seal 58 and the duckbill seal 62. The duckbill
seal 62 forms the channel or zero-closure seal to seal a working
channel of the larger sealing port 22a when no instrument is
disposed therethrough to prevent leakage of insufflation gases
delivered through the surgical access device 10 to a body cavity.
The duckbill seal 62 will generally not form a seal around an
instrument inserted therethrough. In use, when a surgical
instrument is passed through the larger sealing port 22a through a
center opening of the fan seal protector 56 and the fan seal 58,
the fan seal 58 can engage and form a seal around an outer surface
of the instrument to thereby prevent the passage of fluids and gas
through the seal. When no instrument is disposed therethrough, the
center opening of the fan seal protector 56 and the fan seal 58
will generally not form a seal in the working channel of the larger
sealing port 22a. A person skilled in the art will appreciate that
while instrument seals in the form of fan seals are shown, any seal
can be used and can be aligned in any way relative to the inner
housing 16. Exemplary instrument seal configurations are described
in more detail in U.S. Patent Publication No. 2004/0230161 entitled
"Trocar Seal Assembly," filed on Mar. 31, 2004, and U.S. patent
application Ser. No. 10/687,502 entitled "Conical Trocar Seal,"
filed on Oct. 15, 2003, which are hereby incorporated by reference
in their entireties. When the instrument is further inserted
through the duckbill seal 62, the instrument can open the duckbill
seal 62 and pass into the working channel 18a of the retractor 18
when the retractor 18 is coupled to the housing 12.
[0081] As mentioned above, the larger sealing element can have any
size, but in an exemplary embodiment, it can be sized for seating
in the inner housing's first port opening having a diameter D1 of
about 15.9 mm and for receiving instruments having shaft diameters
in a range of about 4.7 to 15.7 mm. The fan seal 58 can have an
inner septum having a diameter of less than about 4.7 mm, and the
fan seal protector 56 can have an inner diameter greater than about
5.9 mm. These inner diameters of the fan seal 58 and the fan seal
protector 56 can help protect against seal damage when a relatively
large instrument, e.g., having a shaft diameter in a range of about
10 to 12 mm, is inserted therethrough while also preventing
floating and allowing the fan seal 58 to accommodate insertion of a
smaller instrument, e.g., having a shaft diameter of about 5 mm,
when the reducer cap 52 is attached to the first port opening
22a.
[0082] The smaller sealing elements in the smaller sealing ports
22b, 22c can each include a distal duckbill seal 68 that provides a
channel seal, and a proximal septum seal 66 that provides an
instrument seal. A protective member 64 can be positioned proximal
to the septum seal 66 to protect the septum seal 66 from accidental
puncture. The septum seal 66 can optionally include a beveled edge
on an interior circumference thereof, which can help facilitate
instrument insertion therethrough. If the septum seal 66 has an
interior beveled edge, the protective member 64 can have an inner
diameter substantially equal to an outer diameter of the beveled
circumferential edge, which can help protect the septum seal 66
without floating and without substantially limiting angular
movement of instruments inserted therethrough. The smaller sealing
ports 22a, 22b can generally be used in a manner similar to the
larger sealing port 22a, with an instrument being insertable
through a center opening in the protective member 64 and the septum
seal 66 and then through the duckbill seal 68 and into a working
channel of the retractor 18 when the retractor 18 is coupled to the
housing 12. Although the second and third sealing elements are
configured similar to each other in this embodiment, a person
skilled in the art will appreciate that the second and third
sealing elements can be configured different from one another.
[0083] Each of the distal duckbill seals 62, 68, the fan seal 58,
the fan seal protector 56, and the septum seal 66 can include a
radially-outward extending proximal flange 62a, 68a, 58a, 56a, 66a.
The proximal flanges 62a, 68a, 58a, 56a, 66a can each be captured
between a proximal surface of one of the raised housings 54a, 54b,
54c and an inner distal cylindrical rib or projection formed around
each of the openings 50a, 50b, 50c in the upper portion 16a of the
inner housing 16, thereby seating the sealing elements within their
respective port openings in the inner housing 16. As noted above,
however, the larger sealing port 22a includes a bottom ring 60 and
the smaller sealing ports 22b, 22c include the protective member 64
that are also captured between the upper and lower portions 16a,
16b of the lower housing 16. The upper and lower portions 16a, 16b
of the inner housing 16 can be sealingly engaged, thereby forming a
seal around the sealing ports 22a, 22b, 22c. To seal together, one
or more projections, e.g., cylindrical pegs or prongs 16g (see FIG.
7), can proximally extend from an inner surface of the inner
housing's lower portion 16b and each be inserted into a
corresponding cavity (not shown), e.g., a cylindrical bore, formed
in an inner surface of the inner housing's upper portion 16a.
[0084] As mentioned above, the smaller sealing elements can each
have any size, but in an exemplary embodiment, they can each be
sized for seating in the inner housing's smaller port openings
having diameters D2 in a range of about 6.0 to 7.5 mm and for
receiving instruments having shaft diameters in a range of about
4.7 to 5.9 mm. The septum seal 66 can have an inner diameter in a
range of about 1.9 to 3.4 mm, e.g., about 3.2 mm.
[0085] A person skilled in the art will appreciate that while
channel or zero-closure seals in the form of duckbill seals are
shown for the distal seals 62, 68, any seal, e.g., duckbill seals,
cone seals, flapper valves, gel seals, diaphragm seals, lip seals,
iris seals, non-linear sealing elements such sealing elements with
an S-shaped opening, etc., same or different from any other of the
other distal seals 62, 68 can be used and can be aligned in any way
relative to the inner housing 16. Generally, a zero-closure seal
can be configured to form a seal in a working channel when no
instrument is disposed therethrough to thus prevent the leakage of
insufflation gases delivered through the surgical access device to
the body cavity. A duckbill seal can generally have opposed flaps
that extend at an angle toward one another in a distal direction
and that come together at a distal end to form a seal face. The
opposed flaps can be movable relative to one another to allow the
seal face to move between a closed position, in which no instrument
is disposed therethrough and the seal face seals the working
channel of the surgical access device, and an open position in
which an instrument is disposed therethrough. A duckbill seal can
include various other features, as described in more detail in U.S.
application Ser. No. 11/771,263, entitled "Duckbill Seal with Fluid
Drainage Feature," filed on Jun. 29, 2007, which is hereby
incorporated by reference in its entirety. In addition, the seal
face of the duckbill seal can be in any nonlinear shape or
configuration known in the art, for example in an S-shaped
configuration, as described in more detail in U.S. Pat. No.
5,330,437, entitled "Self Sealing Flexible Elastomeric Valve and
Trocar Assembly for Incorporating Same," filed Nov. 12, 1993, which
is hereby incorporated by reference in its entirety.
[0086] As mentioned above, the sealing ports 22a, 22b, 22c can be
configured to be in a fixed position relative to the inner housing
16 and to rotate with the inner housing 16 relative to the outer
housing 14 and the retractor 18, as discussed further below.
However, any one or more of the sealing ports 22a, 22b, 22c can be
configured to be movable relative to any one or more portions of
the housing 12, such as the inner housing 16, the outer housing 14,
or any others of the sealing ports 22a, 22b, 22c.
[0087] Also as mentioned above and as shown in FIGS. 5-7, the outer
housing 14 can be configured as a substantially rigid cylindrical
or circular member having the inner housing 16 disposed therein.
Although the outer housing 14 can be a singular member or can have
multiple portions mated together in any way, in the illustrated
embodiment, pins 70 proximally extending from an outer perimeter of
the outer housing's lower portion 14b can extend into corresponding
bores (not shown) formed in a circumferential wall of the outer
housing's upper portion 14a to mate the upper and lower portions
14a, 14b together. The circumferential wall of the outer housing's
upper portion 14a and/or the inner housing's upper portion 16a can
optionally include one or more cut-out portions (not shown) formed
therein adjacent to a sealing port 22a, 22b, 22c that are
configured to help angle surgical instruments inserted through the
sealing ports 22a, 22b, 22c.
[0088] The inner housing 16 can be disposed and captured within the
outer housing 14 in a variety of ways. As in the illustrated
embodiment (see FIGS. 3, 5, and 7), the outer housing 14 can
include complementary rotational surfaces configured to engage and
allow rotation of the inner housing 16. A proximal surface of the
inner radially-inward extending circumferential lip 14c formed on
the outer housing's lower portion 14b can form a distal rotational
surface that seats the inner housing 16, while a distal surface of
an inner radially-inward extending circumferential lip 14d formed
the outer housing's upper portion 14a can be a proximal rotational
surface for the inner housing 16. As shown, the inner housing 16,
e.g., the upper portion 16a, can include a circumferential groove
16e formed therein configured to receive the proximal lip 14d of
the outer housing 14. A distal surface of the inner housing 16,
e.g., a distal surface of the lower portion 16b, can be configured
to rest on the distal lip 14c of the outer housing 14, which can
also engage the retractor protector retainer 44 as discussed above.
In this way, the inner housing 16 can rotate relative to the outer
housing 14 by sliding along the inner lips 14c, 14d of the outer
housing 14. The outer housing's inner lips 14c, 14d can also help
prevent the inner housing 16 from tilting when rotating to help
prevent unpredictable movement of one or more instruments inserted
through the inner housing 16.
[0089] As indicated above, the ring assembly 26 can be positioned
between the housing 12 and the retractor 18. Although the ring
assembly 26 can have a variety of sizes, shapes, and
configurations, and can include an integral, single ring, the ring
assembly 26 can, as shown in FIGS. 1-3, 8, and 9, be in the form of
two substantially circular rings 28, 30 releasably mated together
in a fixed position.
[0090] In any and all of the surgical access device embodiments
disclosed herein, an engagement and/or release mechanism can be
included to allow the housing 12 to be separated from the ring
assembly 26, to allow the housing 12 to be separated from the
retractor 18, and/or to allow a sealing element to be removed from
the inner housing 16. Any engagement and release mechanism known in
the art, e.g., a snap-lock mechanism, corresponding threads, etc.,
can be used to releasably mate two components of the device 10. In
one embodiment, the engagement and release mechanism can include a
latch mechanism, as described by way of non-limiting example in
U.S. application Ser. No. 12/242,765 entitled "Surgical Access
Device" filed on Sep. 30, 2008, which is hereby incorporated by
reference in its entirety.
[0091] As illustrated in the embodiment shown in FIGS. 1-10, the
device 10 can include an engagement and release mechanism in the
form of a bayonet latch mechanism. At least one bayonet foot or
pin, e.g., four radially arranged bayonet feet or pins 72 spaced
equidistantly or any other distance apart, can extend any length
from an outer circumference of the housing 12, e.g., from an outer
sidewall of the lower portion 16b of the outer housing 16, and they
can be configured to engage corresponding slots 74 formed in an
inner circumferential surface of the locking ring 28. The slots 74
can have any shape and size and can be the same as or different
from any other of the slots 74. As discussed further below, the
slots 74 can each include a vertically-extending portion in which
the pins 72 can be proximally inserted and a laterally-extending
portion in which the pins 72 can laterally slide. The bayonet pins
72 can have any shape and size and can be the same as or different
from any other of the pins 72. The bayonet pins 72 on the outer
housing 16 can be configured to be lowered into the
vertically-extending portion of the slots 74 in the locking ring
28. Because the pins 72 can be properly aligned for insertion into
the slots 74 in a predetermined number of rotational orientations,
e.g., four predetermined orientations about 45.degree. apart from
each other as in the illustrated embodiment, the outer housing 16
can be attached to the locking ring 28 in a predictable
orientation. Such predictability can allow the insufflation port 34
to be positioned in a desirable location. The bayonet pins 72 can
be configured, as shown, to be identical and interchangeably
lowered into any of the slots 74 in the locking ring 28. In some
embodiments, any one or more of the bayonet pins 72 can differ from
one another, and one or more of the slots 74 can correspondingly
differ, such that the outer housing 14 can be configured to mate to
the locking ring 28 in one or more predetermined rotational
orientations, e.g., with different circumferentially arranged
bayonet pins aligned with their corresponding different
circumferentially arranged slots. In an embodiment where each of
the bayonet pins 72 differs from one another and each of the slots
74 correspondingly differs from one another, the outer housing 14
can only be positioned in one predetermined rotational orientation
relative to the locking ring 28 where the bayonet pins can each be
simultaneously lowered into the corresponding slots. Embodiments of
differing bayonet pins are described in more detail in previously
mentioned U.S. application Ser. No. 12/399,482 entitled "Methods
and Devices for Providing Access to a Body Cavity" filed on Mar. 6,
2009.
[0092] With the bayonet pins 72 engaging their corresponding slots
74, the outer housing 16, with the inner housing 14 and the
retractor protector 42 coupled thereto, can then be rotated in a
first direction, e.g., a clockwise direction, relative to the
locking ring 28, thereby causing the bayonet pins 72 to travel
laterally within the slots 74, e.g., within the laterally-extending
portion of the slots 74, to a position in which the pins 72 abut
terminal ends 74a of the slots 74, thereby locking the outer
housing 16 to the locking ring 28. One or more of the slots 74 can
angle proximally or distally (not shown) at their respective
terminal ends 74a such that the bayonet pins 72 can proximally or
distally slide and snap into the terminal ends 74a to help ensure
that the bayonet pins 72 fully slide through the slots 74 to lock
the housing 12 to the locking ring 28. In the illustrated
embodiment, the bayonet pins 72 can only move in one, predictable
direction, e.g., clockwise, to lock the outer housing 16 to the
locking ring 28 because the laterally-extending portions of the
slots 74 extend in that one, predictable direction from the
vertically-extending portions of the slots 74. In some embodiments,
the laterally-extending portions of the slots 74 can additionally
or alternatively extend in a counter clockwise direction. Before
being attached to the locking ring 28, the outer housing 16 can be
pre-attached to a remainder of the housing 12, and the locking ring
28 can be pre-attached to the retractor ring 30 and the retractor
18, thereby allowing the device 10 to be fully assembled upon
locking the outer housing 16 to the locking ring 28. The housing
12, e.g., an outer surface of the outer housing 14, can optionally
include surface features, e.g., ridges, bumps, textured surface,
etc., to help facilitate gripping and turning of the housing
12.
[0093] The outer housing 14 can optionally include a selectively
engageable locking mechanism configured to alternatively allow
locking of the outer housing 14 and the locking ring 28 and allow
removal of the outer housing 14 from the locking ring 28. Although
the locking mechanism can have a variety of configurations as will
be appreciated by a person skilled in the art, in the illustrated
embodiment the locking mechanism includes a depressible tab 76 on
the outer housing 14. The tab 76 can have an engaged position for
mating the outer housing 14 to the locking ring 28 in a fixed
position such that the outer housing 14 cannot rotate, and have a
released position for allowing rotation of the outer housing 14 and
release of the outer housing 14 from the locking ring 28. The tab
76 can be configured to automatically be in the engaged position
when the pins 72 reach the terminal ends 74a of the slots 74, and
can be configured to be selectively movable from the engaged
position to the released position by pressing and holding the tab
76 down while rotating the outer housing 14. As shown in FIG. 10,
an inner surface of the tab 76 can have a protrusion 78 formed
thereon that is configured to engage the locking ring 28. The
protrusion 78 can have any size and shape such as a longitudinally
extending bar (as shown) that distally extends a distance beyond a
distal surface of the outer housing's upper portion 16a. The
locking ring 28 can have a corresponding depression 80 configured
to receive the protrusion 78. The depression 80 can also have any
size and shape, such as a rectangular channel (as shown). When the
pins 72 are inserted into the slots 74 and rotated in the first
direction relative thereto such that the pins 72 abut the terminal
ends 74a of the slots 74, the protrusion 78 can automatically
engage the depression 80, e.g., by moving radially outward to snap
therein. The tab 76 can be held in the released position when the
pins 72 are inserted into the slots 74 to help prevent the
protrusion 78 from interfering with attachment of the outer housing
14 to the locking ring 28. To move the tab 76 from the engaged to
the released position, the tab 76 can be pressed radially inward to
move the protrusion radially inward and out of engagement from the
depression 80.
[0094] With the housing 12 locked to the locking ring 28, e.g.,
with the pins 72 abutting the slot's terminal ends 74a and with the
locking mechanism in the engaged position, the inner housing 16 can
be rotated in the first direction, e.g., a clockwise direction, and
in the second, opposite direction, e.g., a counter clockwise
direction, to rotate the inner housing 16 relative to the outer
housing 14 as well as to the locking ring 28 and to the retractor
18 when the locking ring 28 is attached thereto. As shown, the
inner housing 16 can be configured to rotate 360.degree.. While the
inner housing 16 can be configured to be rotatable in only one of
the first and second directions and/or less than 360.degree., the
inner housing 16 as illustrated is rotatable 360.degree. in both
the first and second directions, which can help more effectively
position surgical instruments inserted through the inner housing 16
with respect to each other. As mentioned above, the retractor
protector 42 can rotate with the inner housing 16, thereby allowing
the retractor protector 42 to maintain a consistent orientation
relative to any surgical instruments inserted through the inner
housing 16 and into the retractor 18.
[0095] Although the inner housing 16 can be configured to be
movable relative to the outer housing 14 and the retractor 18 with
or without any instruments inserted through any of the sealing
ports 22a, 22b, 22c, e.g., by being manually rotated by hand, the
inner housing 16 can also be configured to move relative to the
outer housing 14 and the retractor 18 in response to motion of at
least one instrument inserted through one of the ports 22a, 22b,
22c.
[0096] If disengagement of the outer housing 16 and the locking
ring 28 is desired, e.g., to replace the housing 12 with another
housing having a different number or different sizes of sealing
ports or to replace the retractor 18, the outer housing 16 can be
rotated in the second direction such that the bayonet pins 72 are
free to be withdrawn from the slots 74. If the device 10 includes a
locking mechanism, it can be moved from the engaged position to the
released position, e.g., by depressing the tab 76, to allow
rotation and removal of the outer housing 14 from the locking ring
28.
[0097] In use, one or more surgical instruments can be inserted
into a body cavity through the surgical access device 10, which can
help optimally position the surgical instruments relative to the
body cavity through movement of the inner housing 16 relative to
the retractor 18. The device 10 can be positioned within tissue to
provide access to a body cavity underlying the tissue in a variety
of ways. In one embodiment, the device 10 can be positioned in
tissue fully assembled in the default position shown in FIGS. 1 and
3. In another embodiment, the device 10 can be positioned partially
assembled in tissue and be fully assembled with a portion of the
device 10 positioned in the tissue. The various elements of the
device 10 can be attached together in any order. In one embodiment,
the device 10 can be positioned in tissue by first positioning the
retractor 18 therein, attaching the ring assembly 26 to the
retractor 18 positioned in the tissue, and then attaching the
housing 12 to the ring assembly 26.
[0098] The retractor 18 can be positioned within an opening or
incision formed in tissue (generally referred to as an "opening"),
e.g., in the umbilicus, with the proximal and distal flanges 29, 31
of the retractor 18 positioned on opposed sides of the tissue. The
opening can have any shape and size, e.g., a linear cut having a
longitudinal length in a range of about 15 to 35 mm and extending
through a layer of tissue having a depth of less than about 70 mm.
The retractor 18 can be positioned within a tissue opening in a
variety of ways. In one embodiment, shown in FIGS. 11-14, the
retractor 18 can be positioned in the opening by hand.
[0099] As shown in FIG. 11, while holding the proximal flange 29 of
the retractor 18, the distal flange 31 can be pushed down or
distally to flex the inner elongate portion 32 of the retractor 18.
Then, as shown in FIG. 12, the distal flange 31 can be pushed up or
proximally to push the distal flange 31 partially through the inner
lumen 18a of the retractor 18 such that the distal flange 31 is in
an angled position through the inner lumen 18a. Any amount of the
distal flange 31 can be pushed through the retractor's inner lumen
18a, e.g., about one-third of the distal flange 31 above or
proximal to the proximal flange 29. With the distal flange 31 in
the angled position, the retractor 18 can be positioned in an
opening 82 in tissue 84. As illustrated in FIG. 13, opposing the
distal flange 31, a finger can be inserted distally through the
retractor's inner lumen 18a. Grasping the proximal flange 29 and
the portion of the distal flange 31 extending above the proximal
flange 29, and with the proximal flange 29 positioned above or on a
proximal surface 84a of the tissue 84 outside the patient, the
angled-down portion of the distal flange 31 can be inserted through
the tissue opening 82 and into a body cavity 86 underlying the
tissue 84. When the distal flange 31 passes into the body cavity 86
and is positioned under or on a distal surface 84b of the tissue
84, a remainder of the distal flange 31 can be pushed through the
opening 82 to be positioned in the body cavity 86 under or on the
tissue's distal surface 84b. The retractor 18 can thus be
positioned in the tissue opening 82, as illustrated in FIG. 14,
with the proximal flange 29 of the retractor 18 positioned on
and/or proximal to the proximal surface 84a of the tissue 84, and
the distal flange 31 of the retractor 18 positioned on and/or
distal to the distal surface 84b of the tissue 84 in the body
cavity 86. The inner elongate portion 32 of the retractor 18 can
thereby be positioned within the tissue 84 with the inner lumen 18a
of the retractor 18 extending through the tissue to provide a path
of access to the body cavity 86. Also as shown in FIG. 14, a finger
can be inserted through the retractor's inner lumen 18a and swept
along a margin between the distal flange 31 and the tissue's distal
surface 84b to tactilely confirm that the distal flange 31 is
positioned in the body cavity 86 against the tissue's distal
surface 84b and not trapped in the tissue opening 82. The
retractor's seating in the tissue 84 can alternatively or
additionally be visually identified, e.g., using an endoscope.
[0100] In another embodiment, shown in FIGS. 21-25, the retractor
18 can be positioned in an opening in tissue using an inserter tool
88, illustrated in FIGS. 15-20. Although the inserter tool 88 is
shown in FIGS. 21-25 in use with the retractor 18 of the device 10
of FIGS. 1-3, a person skilled in the art will appreciate that the
inserter tool 88 can be used with any flexible retractor configured
to be positioned in an opening in tissue.
[0101] The inserter tool 88 can have a variety of sizes, shapes,
and configurations. As shown in the embodiment illustrated in FIGS.
15-20, the inserter tool 88 can include an elongate shaft 90 having
a proximal handle portion 90a, a distal retainer portion 90b, and a
mid-portion 90c extending therebetween. Generally, the handle
portion 90a can be configured to be held and manipulated outside a
body of a patient while the retainer portion 90b and the
mid-portion 90c can be configured to be at least partially inserted
into the patient's body to position a retractor in a tissue
opening. The retainer portion 90b can include a channel 96
extending longitudinally through at least a portion thereof, the
channel 96 being configured to releasably couple to a retractor, as
discussed further below.
[0102] The inserter tool 88 can be made from any combination of
rigid and/or flexible materials, but in an exemplary embodiment the
materials are biocompatible and suitable for use in surgical
procedures. A person skilled in the art will appreciate that the
term "flexible" as used herein is intended to encompass a variety
of configurations. Generally, a "flexible" member is one which to
at least some degree of elasticity is capable of bending or
deforming without breaking. In an exemplary embodiment, the
inserter tool 88 or at least portions thereof are composed of at
least one biocompatible and flexible material, such as an
elastomer, e.g., polyurethane, having a durometer in a range of
about 35 to 65 Shore A, e.g., about 55 Shore A.
[0103] The inserter tool's shaft 90 can have any size, shape, and
configuration, as will be appreciated by a person skilled in the
art. The shaft 90 can be rigid, flexible, or a combination thereof,
but in the illustrated embodiment it is flexible along its
longitudinal length 90L. The handle portion 90a, the distal
retainer portion 90b, and the mid-portion 90c can have varying
degrees of flexibility, such as shown with the shaft 90 having a
variable thickness. In an exemplary embodiment, the handle portion
90a has a largest thickness 92a and is the least flexible portion
of the shaft 90, the retainer portion 90b has a smallest thickness
92b and is the most flexible portion of the shaft 90, and the
mid-portion 90c has a thickness 92c and a flexibility between the
terminal end portions 90a, 90b. By being formed of a relatively
soft elastomer and having a relatively small thickness 92b, the
retainer portion 90b can have enough structural integrity to be
advanced through a tissue opening and be configured to flex without
breaking and to dynamically return from a flexed position to a
default or straight position, e.g., as shown in FIGS. 15-20.
[0104] The shaft 90 can vary in longitudinal length depending on
the device's intended application. The proximal handle portion 90a,
the distal retainer portion 90b, and the mid-portion 90c of the
shaft 90 can also each have any respective longitudinal lengths
94a, 94b, 94c along the shaft 90 that added together equal the
device's longitudinal length 90L, e.g., about 12.2 in. (31.0 cm).
In an exemplary embodiment, the retainer portion 90b and the
mid-portion 90c can each be about 25% of the tool's longitudinal
length 90L, and the handle portion 90a can be about 50% of the
tool's longitudinal length 90L.
[0105] The shaft 90 can be formed from a single component or
multiple segments. The flexibility of the shaft 90, as well as its
relatively small thickness, e.g., a maximum of about 0.55 in.
(13.97 mm), can allow the tool 88 to be used in endoscopic
procedures, whereby the tool 88 is introduced translumenally
through a natural or artificial orifice. In an exemplary
embodiment, the shaft 90 can have a substantially rectangular
cross-section with rounded edges (see FIGS. 19 and 20), which can
help ease the shaft's passage into an opening in tissue and prevent
the shaft 90 from harming or getting caught on tissue.
[0106] The shaft 90 can have a uniform or non-uniform outer width
along its longitudinal length 90L. In the illustrated embodiment,
the handle portion 90a of the shaft 90 has a substantially uniform
outer width W1 along its longitudinal length 94a while a remaining
portion 90b, 90c of the shaft 90, e.g., a distal portion of the
tool 88 configured to be at least partially inserted through
tissue, has a smaller substantially constant width W2 along its
longitudinal length 94b, 94c.
[0107] Generally, the retainer portion 90b of the tool 88 can be
configured to mate to a retractor, to deliver the retractor through
a tissue opening, and to dynamically or automatically release the
retractor into position within the tissue opening. A distal
insertion tip 102 can be located at a distal-most end 100 of the
retainer portion 90b to help ease insertion of the retainer portion
90b into a body of a patient, such as by the distal tip 102 having
a rounded tip as illustrated in this embodiment. The distal tip 102
can be substantially flat, or it can taper or slope any number of
degrees, such as shown in FIG. 18 with an upward angle .alpha. of
about 4.degree., to help facilitate distal advancement of the
distal tip 102 through tissue. Opposed side rails 108a, 108b in the
retainer portion 90b defining the channel 96 can taper down to the
distal tip 102.
[0108] As mentioned above, the retainer portion 90b can include the
channel 96 formed therein that can be configured to hold and
release a retractor. The channel 96 can have any longitudinal
length along the shaft 90 and can have a variety of shapes, size,
and configurations. As shown in the illustrated embodiment, the
channel 96 can extend to a proximal end of the retainer portion 90b
from a location proximal to a distal-most end 100 of the shaft 90,
e.g., between the distal tip 102 and the mid-portion 90c. In this
way, a retractor held in the channel 96 can be prevented from
sliding distally beyond the distal-most end 100 of the shaft 90.
The channel 96 can have any shaped cross-section, e.g., a generally
c-shaped cross-section (as shown), defined by the opposed side
rails 108a, 108b and a lower surface 112 of the shaft 90 in the
retainer portion 90b and having an opening extending through an
upper surface 106 of the shaft 90. By having a substantially curved
cross-sectional shape, the channel 96 can be less likely to damage
a retractor disposed therein. As in the illustrated embodiment, the
channel 96 can include first and second longitudinally extending
recesses 104a, 104b separated by a longitudinally extending rib 116
extending upwards from the bottom surface 112 into the channel 96.
The rib 116 can help provide structural integrity to the retainer
portion 90b while allowing the bottom surface 112 of the shaft 90
between the rib 116 and the side rails 108a, 108b to be thin to aid
in flexibility of the retainer portion 90b. The recesses 104a, 104b
can each have generally c-shaped cross-sections, which can allow
the recesses 104a, 104b to seat opposed portions of a flexible ring
such as a proximal or distal flange of a retractor, e.g., the
proximal flange 29 or the distal flange 31 of the retractor 18 of
FIGS. 1-3. The proximal and distal flanges 29, 31 in the
illustrated retractor embodiment are identical substantially
circular rings having the flexible o-rings 29a, 31a disposed
therein, which can allow either of the flanges 29, 31 to be
positioned in the channel 96 and either to form the distal portion
of the retractor 18 disposed in a body cavity of a patient. Such
interchangeability can help reduce delay during a surgical
procedure. Although the channel 96 is configured to seat the one of
the flanges 29, 31 in the illustrated embodiment such that the
retractor 18 can extend outward from the shaft 90 when mated to the
inserter tool 88, the channel 96 can be configured to seat any
portion of a retractor.
[0109] To help retain a retractor in position within the channel
96, the inserter tool 88 can include one or more retention members
configured to prevent the retractor from being prematurely released
from the tool 88. As will be appreciated by a person skilled in the
art, the retention members can have a variety of shapes, sizes, and
configurations. In the illustrated embodiment, the inserter tool 88
includes first and second retention members 110a, 110b each
extending adjacent to the shaft's upper surface 106 from one of the
opposed side rails 108a, 108b and radially inward toward the
channel 96. The retention members 110a, 110b, as shown, can be at
the same axial position A along the shaft's longitudinal axis L and
can each be in the form of identical, substantially flat,
bullet-shaped protrusions having rounded distal tips. The retention
members 110a, 110b can extend any distance from the side rails
108a, 108b and over the channel 96 such that the retention members
110a, 110b can be configured to prevent the portion of the
retractor disposed in the channel 96 from being pulled laterally
out of the channel 96, e.g., from being pulled through the
channel's opening and away from the shaft's upper surface 106. In
an exemplary embodiment the retention members' distal tips do not
touch, thereby allowing the portion of the retractor retained in
the channel 96 to be released from between the retention members
110a, 110b, as discussed further below.
[0110] Generally, the mid-portion 90c can be configured to
facilitate insertion of the retainer portion 90b within a tissue
opening by being at least partially insertable into the tissue
opening. The mid-portion 90c can have a variety of sizes, shapes,
and configurations. As shown in this embodiment, the mid-portion
90c can include indicia 114 printed, embossed, or otherwise visible
thereon that is configured to indicate an insertion depth of the
shaft 90 through an opening in tissue and into a body cavity. As
will be appreciated by a person skilled in the art, the indicia 114
can have a variety of sizes, shapes, and configurations. In the
illustrated embodiment, the indicia 114 includes a plurality of
lines printed circumferentially around the shaft 90 that are
perpendicular to the shaft's longitudinal axis L. The mid-portion
90c can include any number of lines, and the lines can be spaced
apart any distance to indicate various degrees of insertion depth,
e.g., seven lines spaced about 1 cm apart and numbered one to seven
in a proximal direction.
[0111] Generally, the handle portion 90a can be configured to
facilitate grasping of the tool 88. The handle portion 90a can have
a variety of sizes, shapes, and configurations. Non-limiting
examples of the handle portion 90a include an elongate rod (as
shown), a finger loop, a knob, an enlarged grip, etc. The handle
portion 90a can optionally include one or more hand or finger grips
98, e.g., an indented and/or textured surface, configured to help
facilitate secure, non-slip grasping of the tool 88. The handle
portion 90a can form a non-insertion section of the tool 88, e.g.,
a section of the tool 88 not configured to be inserted into a body
of a patient, while a remainder of the tool 88, e.g., the
mid-portion 90c and the retainer portion 90b, can form an insertion
section of the tool 88, e.g., a section of the device 10 configured
to be inserted at least partially into a body of a patient.
[0112] Although as mentioned above the inserter tool 88 can be used
with any retractor, the tool 88 is illustrated in use in FIGS.
21-25 to position the retractor 18 of FIGS. 1-3 in the opening 82
formed in the tissue 84. To mate the retractor 18 to the tool 88,
the retractor's distal flange 31 can be pinched together as shown
in FIG. 21 from an expanded, default configuration (as shown in
FIGS. 1-3) to a collapsed configuration and inserted into the
channel 96 in the distal retainer portion 90b of the tool 88. The
distal flange 31 can be positioned in the collapsed configuration
under the retention members 110a, 110b as shown in FIG. 22 to help
retain the retractor 18 in the tool 88. Also as shown in FIG. 22,
each retention member 110a, 110b can radially extend inwards a
distance larger than a cross-sectional diameter of the distal
flange 31 to further help prevent the distal flange 31 from
prematurely sliding out of the channel 96.
[0113] With the retractor 18 disposed in the channel 96 of the tool
88, the tool 88 and the retractor 18 can be inserted into the
tissue opening 82, as shown in FIG. 23. As will be appreciated by a
person skilled in the art, to facilitate installation of the
retractor 18 in the tissue opening 82 using the inserter tool 88, a
lubricant (not shown), e.g., water based surgical lubricant, can be
applied to the inserter tool 88. The lubricant can be applied at
any time during a surgical procedure, such as following mating of
the retractor 18 to the tool 88 but prior to insertion of the tool
88 through the tissue 84. With the retractor 18 mated to a distal
portion thereof, the inserter tool 88 can be inserted distal tip
102 first into the tissue opening 82 and advanced distally with
light, controlled, downward pressure. The tool 88 can be held and
inserted substantially perpendicular to the proximal surface 84a of
the tissue 84, as illustrated in FIG. 23, which can help allow the
tapered distal tip 102 to enter and dilate the tissue opening 82
and the proximal flange 29 of the retractor 18 to abut and remain
outside the tissue's proximal surface 84a.
[0114] As the inserter tool's distal tip 102 and the retractor 18
enter the body cavity 86 underlying the tissue 84, as shown in FIG.
24, the inserter tool 88 can be angled to flex at least the
retainer portion 90b of the shaft 90 and direct at least the
retainer portion 90b of the shaft 90 in a direction parallel to the
body cavity 86 and the inner or distal surface 84b of the tissue
84, which can help prevent the tool 88 and/or the retractor 18 from
interfering with vessels or other anatomic structures underlying
the tissue 84. Such angling can also help direct the proximal
flange 29 of the retractor 18 to engage and be substantially
parallel to the tissue's proximal surface 84a. The indicia 114 on
the inserter tool 88 can help indicate an insertion depth of the
tool 88 inserted through the tissue opening 82, which can help
indicate when the retractor 18 has entered the body cavity 86. For
non-limiting example, if the tissue opening 82 is about 4 cm deep
and the line marked "4" is substantially at the outer or proximal
surface 84a of the tissue 84, then the retractor 18 has likely been
inserted into the body cavity 86. With the proximal flange 29 of
the retractor 18 engaging the tissue's proximal surface 84a,
flexing the retainer portion 90b can allow release of the distal
flange 31 of the retractor 18 from the tool 88. When the retainer
portion 90b is flexed enough for the retractor 18 held therein to
apply a predetermined force to the channel 96 that exceeds a force
holding the proximal flange 29 of the retractor 18 outside the
tissue 84, the side rails 108a, 108b can radially move apart from
one another such that the channel 96 can widen in at least a
portion thereof and the retention members 110a, 110b) can radially
move apart from one another, thereby allowing the channel 96 to
release the retractor 18 into position within the tissue opening
82, as shown in FIG. 25. The predetermined force can vary and can
generally be based on the material used to form the tool's retainer
portion 90b and on the thickness 92b of the retainer portion 90b.
Release of the retractor 18 from the tool 88 can be felt through
the handle portion 90c held outside the body. With the distal
flange 31 released from the tool 88, the retractor 18 can be
positioned within the tissue opening 82 as shown in FIG. 25 with
the proximal and distal flanges 29, 31 positioned on opposite sides
of the tissue 84. With the retainer portion 90b being formed of a
relative soft elastomer and having the retractor 18 released
therefrom, the retainer portion 90b can relatively slowly flex back
to its default position rather than harshly snapping back into the
default position and potentially damaging the tissue 84 or other
anatomical structure.
[0115] To remove the tool 88 from the body, the tool 88 can be
rotated clockwise and/or counter-clockwise in any amount, e.g.,
about 180.degree., and withdrawn from the tissue opening 82 as also
shown in FIG. 25. The retractor 18 can thus be positioned in the
tissue opening 82, as illustrated in FIG. 14, with the proximal
flange 29 of the retractor 18 positioned on and/or proximal to the
proximal surface 84a of the tissue 84, and the distal flange 31 of
the retractor 18 positioned on and/or distal to the distal surface
84b of the tissue 84 in the body cavity 86. The inner elongate
portion 32 of the retractor 18 can thereby be positioned within the
tissue 84 with the inner lumen 18a of the retractor 18 extending
through the tissue 84 to provide a path of access to the body
cavity 86. Also as shown in FIG. 14, a finger can be inserted
through the retractor's inner lumen 18a and swept along a margin
between the distal flange 31 and the tissue's distal surface 84b to
tactilely confirm that the distal flange 31 is positioned in the
body cavity 86 against the tissue's distal surface 84b and not
trapped in the tissue opening 82. The retractor's seating in the
tissue 84 can alternatively or additionally be visually identified,
e.g., using an endoscope.
[0116] With the retractor 18 positioned in the tissue 84, either by
hand or through use of the inserter tool 88, the ring assembly 26
and the housing 12 can be attached to the retractor 18. Although,
as mentioned above, in some embodiments the ring assembly 26 with
or without the housing 12 attached thereto can be mated to the
retractor 18 when the retractor 18 is positioned in a tissue
opening. In an exemplary embodiment, as shown in FIG. 26, the
locking ring 28 and the retractor ring 30 can be attached together,
and then the retractor ring 30 can be mated to the proximal flange
29 of the retractor 18 positioned outside the body. If the tissue
84 and/or the retractor 18 are adequately flexible, the retractor
18 can be angled or pivoted to a desired position to ease
attachment of the retractor ring 30 to the retractor 18. The
retractor 18 can also be angled or pivoted during use of the device
10 with one or more surgical instruments inserted therethrough. To
mate the retractor ring 30 and the retractor 18, the retractor's
proximal flange 29 can be pulled by hand and/or with one or more
surgical instruments through an inner lumen of the retractor ring
30 to position the proximal flange 29 on an inner circumferential
lip 30a of the retractor ring 30 (see FIGS. 3 and 9). The inner
circumferential lip 30a can continuously run circumferentially
around the retractor ring 30 as shown, or the inner circumferential
lip 30a can run around one or more discrete portions of the
retractor ring 30. The inner circumferential lip 30a of the
retractor ring 30 can optionally include a beveled surface, which
can help secure the retractor 18 to the proximal portion 24 of the
device 10 as discussed further below. The retractor ring 30 can
thus have the proximal flange 29 disposed therein to couple the
retractor 18 and the ring assembly 26 together.
[0117] With the retractor 18 positioned in the tissue 84 and having
the ring assembly 26 attached thereto, the housing 12 can be
attached to the ring assembly 26 and the retractor 18 as shown in
FIG. 27 to fully assemble the device 10. Although, as mentioned
above, in some embodiments the housing 12 can be attached to the
ring assembly 26 when the ring assembly 26 is mated to the
retractor 18. To mate the housing 12 to the ring assembly 26 and
the retractor 18, the housing 12 can be positioned proximal to the
ring assembly 26 and the retractor 18 with a distal portion of the
housing 12 engaging a proximal portion of the ring assembly 26 and
the retractor 18, e.g., a distal portion of the housing 12 engaging
the locking ring 28. As mentioned above, the bayonet pins 72 of the
housing 12 can be positioned in the slots 74 of the locking ring
28, and the housing 12 can be rotated relative to the locking ring
28 to lock the housing 12 thereto. The tissue 84 can provide
adequate tension such that the locking ring 28, attached to the
retractor 18 positioned in the tissue 84, need not be held in
position while the housing 12 is rotated relative thereto, although
the ring assembly 26 and/or the retractor 18 can be so held to help
provide support to the device 10 during its assembly.
[0118] The outer housing 14 and the retractor ring 30 can each
include a beveled surface configured to engage the proximal flange
29 of the retractor 18 therebetween. The beveled surfaces can help
accommodate an uneven surface of the proximal flange 29 that can
result from a bonded edge created during manufacture of the
proximal flange 29, e.g., when the proximal o-ring 29a is
positioned therein as discussed above. The bonded edge can have an
uneven size and/or shape on a single retractor and can also vary in
size and/or shape between individual retractors. The beveled
surfaces can thus improve the compatibility of the proximal portion
24 of the device 10 with a variety of retractors. As shown in FIGS.
3, 5, and 7, the lower portion 14b of the outer housing 14 can
include a beveled distal surface of the distal lip 14c configured
to cooperate with a beveled proximal surface of the inner
circumferential lip 30a of the retractor ring 30. The beveled
distal surface of the distal lip 14c and the beveled proximal
surface of the inner circumferential lip 30a can each angle
radially inward and proximally upward as illustrated to help hold
the proximal flange 29 therebetween and provide adequate space for
the flange's bonded edge.
[0119] With the surgical access device 10 assembled and positioned
in the tissue 84, as shown in FIG. 28, one or more surgical
instruments 118 can be inserted therethrough through any one or
more of the sealing ports 22a, 22b, 22c and into the body cavity 86
where the instruments 118 can help perform any type of surgical
procedure. Prior to insertion of the instrument 118 through the
device 10, insufflation can be provided using the insufflation port
34, the tubing 36, and the stopcock 38. Although the surgical
instrument 118 shown in FIG. 28 is a grasper having a pair of
distal movable jaws, a person skilled in the art will appreciate
that any surgical instrument can be inserted through the device 10.
Further, although the instrument 118 is illustrated as being
inserted through the larger sealing port 22a with the reducer cap
52 attached thereto, as mentioned above, an instrument can be
inserted through the larger sealing port 22a with the reducer cap
52 removed therefrom.
[0120] At any point before, during, or after a surgical procedure,
part of all of the proximal portion 24 of the device 10 can be
released from the retractor 18, and the retractor 18 can be removed
from the tissue. To disengage the housing 12 from the ring assembly
26 and the retractor 18, the housing 12 can be rotated relative to
the ring assembly 26 and the retractor 18. As mentioned above, the
tab 76 can be depressed to allow such rotation. The engagement and
release mechanism can then be disengaged, e.g., the housing 12 can
be proximally moved to disengage the bayonet pins 72 from the
openings 74. The tissue 84 can provide adequate tension for the
proximal motion of the housing 12.
[0121] With the housing 12 of the device 10 disengaged from the
ring assembly 26 and the retractor 18, the working channel 18a of
the retractor 18 can still provide access to the body cavity 86
underlying the tissue 84. With or without any or all of the ring
assembly 26 removed from the retractor 18, one or more surgical
instruments can be advanced through the working channel 18a, such
as a waste removal bag configured to hold waste material, e.g.,
dissected tissue, excess fluid, etc., from the body cavity 86. The
bag can be introduced into the body cavity 86 through the
retractor's working channel 18a or other access port. A person
skilled in the art will appreciate that one or more surgical
instruments can be advanced through the retractor's working channel
18a before and/or after the housing 12 and/or the ring assembly 26
has been attached to the retractor 18.
[0122] The retractor 18 can be removed from within the tissue
opening 82 in any way. In some embodiments, the retractor 18 can be
pulled out of the opening 82 by hand, e.g., by inserting a finger
through the retractor's inner lumen 18a and pulling the distal
flange 31 from the body cavity 86 through the proximal flange 29.
In some embodiments, a string, thread, suture, or cord (generally
referred to as a "cord") can be used to help remove the retractor
18 from the tissue 84, with or without the housing 12 and/or the
ring assembly 26 being attached to the retractor 18. The cord can
have a variety of sizes, shapes, and configurations. Generally, the
cord can be a surgically safe flexible material, such as umbilical
tape.
[0123] The cord can be coupled to the retractor 18 before or after
the retractor is positioned in the tissue opening 82. In one
embodiment shown in FIGS. 29-31, a cord 120 can be positioned in
the tissue opening 82 before placement of the retractor 18 therein.
Although the retractor 18 is shown being inserted into the tissue
84 in FIGS. 30 and 31 using the inserter tool 88, the retractor 18
can be positioned in the tissue 84 by hand as discussed above.
Further, also as discussed above, the retractor 18 can be
positioned in the tissue 84 with any part of the device's proximal
portion 24 attached thereto. In use, as shown in FIG. 29, the cord
120 can be inserted into the tissue opening 82 such that the cord
120 is in an extended configuration with a first terminal end 120a
of the cord 120 disposed in the body cavity 86 and a second
terminal end 120b of the cord 120 located outside the body of the
patient. With the cord 120 in the extended configuration, the
retractor 18 can be positioned in the tissue opening 82 using the
inserter tool 88 as discussed above and as illustrated in FIGS. 30
and 31. The inserter tool 88 can be removed from the body, and a
length of the cord 120 can be positioned between the tissue 84 and
the retractor 18 in the tissue opening 82 with the cord's first and
second terminal ends 120a, 120b remaining on opposite sides of the
tissue 84. The first terminal end 120a of the cord 120 can be
pulled through the retractor's working channel 18a by hand and/or
with at least one surgical instrument from inside the body cavity
86 to a location outside the body of the patient, such that the
cord 120 can be in a looped configuration around the retractor 18
as shown in FIG. 32 with the cord 120 extending through the
retractor's working channel 18a, around the distal flange 31, and
between the retractor's flexible inner elongate portion 32 and the
tissue 84. Thus, while the cord 120 can have any longitudinal
length, in an exemplary embodiment the cord's longitudinal length
can be at least twice a height of the retractor 18.
[0124] In another embodiment shown in FIG. 33, the cord 120 can be
pre-threaded through the retractor 18 in the looped configuration,
before or after the retractor 18 is mated to the inserter tool 88.
The inserter tool 88 can then be used to position the retractor 18
in the tissue opening 82 as discussed above to position the
retractor 18 and the cord 120 as shown in FIG. 32.
[0125] With the cord 120 in the expanded or looped configuration
and with the retractor 18 positioned in the tissue 84, the ring
assembly 26 and the housing 12 can be attached to the retractor 18
as discussed above to fully assemble the device 10. While the cord
120 can be positioned anywhere with the proximal portion 24 of the
device 10 mated to the retractor 18, in one embodiment with the
cord 120 in the looped configuration, the cord 120 can be
positioned between the retractor's proximal flange 29 and the lower
portion 14b of the outer housing 14 with the terminal ends 120a,
120b of the cord 120 extending outside the device 10. The cord 120
can be tensioned prior to full assembly of the device 10 to help
minimize a length of the cord 120 extending through the retractor's
working channel 18a. In another embodiment with the cord 120 in the
expanded configuration, the proximal portion 24 of the device 10
can be mated to the retractor 18 with the first terminal end 120a
of the cord 120 located in the body cavity 86.
[0126] At any point during the surgical procedure, the cord 120 can
be used to remove the retractor 18 from the tissue 84. If both
terminal ends 120a, 120b are not located outside the body, part or
all of the proximal portion 24 of the device 10 can be detached
from the retractor 18 to access and position both terminal ends
120a, 120b outside the body. As shown in one embodiment in FIGS. 34
and 35, the retractor 18 can be removed from the tissue 84 using
the cord 120 with the ring assembly 26 attached to the retractor
18. Holding the terminal ends 120a, 120b of the cord 120, the first
terminal end 120a of the cord 120 can be pulled to proximally move
the distal flange 31 through the working channel 18a of the
retractor 18 and out of the body of the patient. Once accessible,
the distal flange 31 can be grasped, in addition to or in
alternative to the cord's first terminal ends 120a, and pulled in a
proximal direction to remove the retractor 18 from the tissue 84.
In this way, with the cord 120 prepositioned between the retractor
18 and the tissue 84, no fingers or surgical instruments need be
introduced any distance into the body to remove the retractor 18
from the tissue 84.
[0127] A surgical drape can optionally be placed over the retractor
18 and the tissue opening 82 during removal of the retractor 18 to
help reduce dispersion of bodily fluid outside the surgical
space.
[0128] As will be appreciated by those skilled in the art, any and
all of the embodiments disclosed herein can be interchangeable with
one another as needed. For example, an exemplary surgical access
device kit could include multiple housings with one or more
retractors. Each housing can have different sealing port
configurations including different types and numbers of sealing
elements, etc. as needed in particular application. Various release
mechanism known in the art can be used to releasably attach the
various housings to a retractor.
[0129] There are various features that can optionally be included
with any and all of the surgical access device embodiments
disclosed herein. For example, a component of the device, such as
an outer housing, retractor, sealing element, etc., can have one or
more lights formed thereon or around a circumference thereof to
enable better visualization when inserted within a patient. As will
be appreciated, any wavelength of light can be used for various
applications, whether visible or invisible. Any number of ports can
also be included on and/or through the surgical access devices to
enable the use of various surgical techniques and devices as needed
in a particular procedure. For example, openings and ports can
allow for the introduction of pressurized gases, vacuum systems,
energy sources such as radiofrequency and ultrasound, irrigation,
imaging, etc. As will be appreciated by those skilled in the art,
any of these techniques and devices can be removably attachable to
the surgical access device and can be exchanged and manipulated as
needed.
[0130] The embodiments described herein can be used in any known
and future surgical procedures and methods, as will be appreciated
by those skilled in the art. For example, any of the embodiments
described herein can be used in performing a sleeve gastrectomy
and/or a gastroplasty, as described in U.S. application Ser. No.
12/242,765 entitled "Surgical Access Device" filed on Sep. 30,
2008; U.S. application Ser. No. 12/242,711 entitled "Surgical
Access Device with Protective Element" filed on Sep. 30, 2008; U.S.
application Ser. No. 12/242,721 entitled "Multiple Port Surgical
Access Device" filed on Sep. 30, 2008; U.S. application Ser. No.
12/242,726 entitled "Variable Surgical Access Device" filed on Sep.
30, 2008; U.S. application Ser. No. 12/242,333 entitled "Methods
and Devices for Performing Gastrectomies and Gastroplasties" filed
on Sep. 30, 2008; U.S. application Ser. No. 12/242,353 entitled
"Methods and Devices for Performing Gastrectomies and
Gastroplasties" filed on Sep. 30, 2008; and U.S. application Ser.
No. 12/242,381 entitled "Methods and Devices for Performing
Gastroplasties Using a Multiple Port Access Device" filed on Sep.
30, 2008, all of which are hereby incorporated by reference in
their entireties.
[0131] The devices disclosed herein can be designed to be disposed
of after a single use, or they can be designed to be used multiple
times. In either case, however, the device can be reconditioned for
reuse after at least one use. Reconditioning can include any
combination of the steps of disassembly of the device, followed by
cleaning or replacement of particular pieces, and subsequent
reassembly. In particular, the device can be disassembled, and any
number of the particular pieces or parts of the device can be
selectively replaced or removed in any combination, e.g., a
housing, a retractor ring, a reducer cap, a distal retainer portion
of an inserter tool, etc. Upon cleaning and/or replacement of
particular parts, the device can be reassembled for subsequent use
either at a reconditioning facility, or by a surgical team
immediately prior to a surgical procedure. Those skilled in the art
will appreciate that reconditioning of a device can utilize a
variety of techniques for disassembly, cleaning/replacement, and
reassembly. Use of such techniques, and the resulting reconditioned
device, are all within the scope of the present application.
[0132] Preferably, the invention described herein will be processed
before surgery. First, a new or used instrument is obtained and if
necessary cleaned. The instrument can then be sterilized. In one
sterilization technique, the instrument is placed in a closed and
sealed container, such as a plastic or TYVEK bag. The container and
instrument are then placed in a field of radiation that can
penetrate the container, such as gamma radiation, x-rays, or
high-energy electrons. The radiation kills bacteria on the
instrument and in the container. The sterilized instrument can then
be stored in the sterile container. The sealed container keeps the
instrument sterile until it is opened in the medical facility.
[0133] It is preferred that device is sterilized. This can be done
by any number of ways known to those skilled in the art including
beta or gamma radiation, ethylene oxide, steam, and a liquid bath
(e.g., cold soak).
[0134] One skilled in the art will appreciate further features and
advantages of the invention based on the above-described
embodiments. Accordingly, the invention is not to be limited by
what has been particularly shown and described, except as indicated
by the appended claims. All publications and references cited
herein are expressly incorporated herein by reference in their
entirety.
* * * * *